All Industry news articles – Page 5
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Industry newsMHRA eligibility checker launched for IRP framework
The MHRA has launched an online eligibility checker tool for applications submitted via its International Recognition Procedure (IRP).
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Industry newsCRISPR tool used to treat sickle-cell and β-thalassemia
Casgevy is the first gene therapy that uses the CRISPR/Cas9 gene-editing tool to be approved by the UK MHRA.
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Industry newsResearchers aim to diagnose Alzheimer’s through blood test
The Blood Biomarker Challenge will aim to determine if a blood test could be used to diagnose people in the early stages of Alzheimer’s disease.
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Industry newsJ&J to submit trial application for surgical robot
Johnson & Johnson’s MedTech division is set to submit its robotic surgical system to the FDA in order to initiate clinical trials.
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Industry newsCyber risk standard gets FDA backing for medical devices
The FDA has encouraged the use of a consensus standard to help device manufacturers address growing concerns over cyber security in devices.
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Industry newsWHO endorses use of R21/Matrix-M malaria vaccine in children
The World Health Organization (WHO) has recommended widespread use of the R21/Matrix-M malaria vaccine in children.
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Industry newsSARS-CoV-2 can cause brain damage in dogs, says study
SARS-CoV-2 can cause changes to the brains of dogs, according to a study published in the CDC’s journal Emerging Infectious Diseases.
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Industry newsPatients warned about falsified Ozempic medication
The EMA has warned patients and healthcare professionals across the EU about pre-filled injection pens falsely labelled as Ozempic.
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Industry newsMHRA seeks to cut approval time by 50% for ‘lowest-risk’ RCTs
The MHRA is set to introduce a new scheme which aims reduce the time taken by the agency to approve the lowest-risk clinical trials.
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Industry newsFDA to establish Digital Health Advisory Committee
The FDA has established a Digital Health Advisory Committee to help the agency explore issues related to digital health technologies (DHTs).
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Industry newsSouth Africa set to investigate J&J over MDR-TB drug pricing
Johnson & Johnson is set to be investigated by South Africa’s Competition Commission for its prices charged for TB drug bedaquiline.
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Industry newsEMA proposes novel method to assess CKD therapy efficacy
Glomerular filtration rate slope can be used as a surragate end point to assess clinical benefit for treatments in CKD in some trial settings.
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Industry newsNICE recommends AI to aid radiotherapy treatment in England
First guidance from National Institute for Health and Care Excellence for use of artificial intelligence as tool for healthcare professionals.
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Industry newsNICE approves use of Rimegepant in NHS to treat acute migraine
Rimegepant is the first, and only, NICE-recommended treatment for acute migraine and is soon to be made available on the NHS in the UK.
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Industry newsFDA committee finds OTC decongestants to be ‘ineffective’
An FDA committee has reviewed phenylephrine − the active ingrediant in many over the counter decongestants − and agreed it is ineffective.
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Industry newsEMA future ‘VetMeds’ for healthy animals and humans; seminar
In the lead up to the EMA’s Veterinary Awareness Day, Ivo Classen sits down to discuss the agency’s progress in the field of veterinary medicines.
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Industry newsCOVID-19 vaccines ‘not to be offered routinely’ to healthy under-65s
Only over-65s will get vaccination offered this year, the Joint Committee on Vaccination and Immunisation has advised UK government.
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Industry newsUK doubles capacity for certification of medical devices
TÜV SÜD, Intertek, and TÜV Rheinland UK have been designated as UK Approved Bodies to assess and certify general medical devices.
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Industry newsMHRA publishes ‘recognition route’ revised guidance
The MHRA has issued guidance on its International Recognition Procedure, which will replace the EC Decision Reliance Procedure from January 2024.
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Industry newsSemaglutide may help with PCOS and addiction disorders
Studies of diabetes and weight-loss drugs are underway to determine if they could also help manage a range of other conditions.